Claudication, Peripheral Artery Disease, Women
Conditions
Brief summary
Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group. Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.
Interventions
BEHAVIORALWalking Exercise
3 times per week for 3 months
BEHAVIORALControl
Resistance training 3 times per week for 3 months
Sponsors
Oklahoma Center for the Advancement of Science and Technology
Milton S. Hershey Medical Center
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* women 60 years of age and older having a positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire * exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol * an ankle/brachial index (ABI) \< 0.90 at rest or \< 0.73 immediately following the treadmill exercise test * at least one year past menopause
Exclusion criteria
* absence of PAD (peripheral artery disease) * asymptomatic PAD (Fontaine stage I) * rest pain due to PAD (Fontaine stage III) * tissue loss due to PAD (Fontaine stage IV) * medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.) * use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation) * cognitive dysfunction (mini-mental state examination score \< 24) * active cancer, renal disease, or liver disease * a calf skin fold measurement \> 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue * pulse arterial oxygen saturation of the index finger \< 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain | 3 months |
| Change in 6-minute walk distance | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in calf muscle oxygen saturation | 3 months |
| Change in daily ambulatory activity | 3 months |
| Change in walking economy | 3 months |
| Change in peak oxygen uptake | 3 months |
Countries
United States
Outcome results
None listed